The Triage Total Controls 5 are assayed materials to be used with the Triage® Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to assist in monitoring test performance.

The Triage Total Calibration Verification 5 materials are to be used with the Triage Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to verify the calibration of the Test Devices throughout the measurable range.

Device Description

The Triage Total Controls 5 Control 1 and 2, and Triage Total Calibration Verification 5 Levels A, B, C, D, E are single-use, 0.29 mL unit dose quality control materials prepared with concentrated purified CK-MB, myoglobin, troponin I, BNP and D-Dimer and human EDTA plasma at defined levels. The controls are stored frozen at < -20℃. Preservatives and stabilizers are added to maintain product integrity. The quality control materials are not calibrators and are not used to calibrate the Triage Test Devices.

AI/ML Overview

The provided text is a 510(k) summary for Triage Total Controls 5 / Triage Total Calibration Verification 5. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information related to specific acceptance criteria or the details of a study that proves the device meets those criteria.

Instead of presenting quantitative acceptance criteria and detailed study results, the document states:

"The stability of the Triage Total Controls 5 and the Triage Total Calibration Verification 5 have been validated according to established procedures at the manufacturing site."
"The performance of the control materials are similar to other products in commercial distribution intended for similar use."
"The Triage Total Controls 5 and Triage Total Calibration Verification 5 employ similar characteristics to the predicate device including multi-analytes assay control, 5 levels, liquid control, EDTA human plasma matrix and ≤ -20℃ storage condition."
"The information presented in this Premarket Notification demonstrates the suitability of the device for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution."

Therefore, based solely on the provided text, I cannot fill out the requested table and answer many of the detailed questions about the study design, sample size, ground truth, and expert involvement.

Here's what can be stated based on the provided text, and where gaps exist:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the document	"stability...validated according to established procedures"
Not specified in the document	"performance...similar to other products in commercial distribution intended for similar use"
Not specified in the document	"substantially equivalent in intended use and performance to the Triage Profiler S.O.B. Controls and the Triage Profiler S.O.B. Calibration Verification Controls"

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "established procedures at the manufacturing site," implying internal company testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is a quality control material for in vitro diagnostic tests, not an AI/imaging device requiring expert interpretation of results for ground truth. Therefore, this question is not applicable in the context of this 510(k) summary. The ground truth for this type of device would typically be established through analytical methods and certified reference materials or established laboratory methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as this is not an AI/imaging device requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a quality control material and not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a quality control material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

While not explicitly stated as "ground truth," the performance of quality control materials is typically verified against:
- Defined levels: The document states they are "prepared with concentrated purified CK-MB, myoglobin, troponin I, BNP and D-Dimer and human EDTA plasma at defined levels." These defined levels act as the analytical "ground truth."
- Established analytical methods: Performance would be compared to expected values using reference methods or the target Triage® test systems.

8. The sample size for the training set

Not applicable. This is a quality control material, not a machine learning model that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. This device does not have a "training set" in the context of machine learning.

Summary

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510(k) Summary of Safety and Effectiveness B.

Triage® Total Controls 5 / Triage® Total Calibration Verification 5

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

K072892

1. Name and Address of Submitter

DEC 0 7 2007 Company Name: Biosite Incorporated Address: 9975 Summers Ridge Road San Diego, CA 92121 Telephone: (858) 805-2722 Telefax: (858) 586-7543 Fil V. Buenviaje Contact Person: Sr. Manager, Regulatory Compliance Date Summary Prepared: October 5, 2007

2. Device Name and Classification

Trade Name:	Triage® Total Controls 5Triage® Total Calibration Verification 5
Common Name:	Not Applicable
Classification of Device:	21 CFR 862.1660,Quality Control Material (Assayed and Unassayed)Product Code: JJY

3. Predicate Devices

K040459 - Triage® Profiler S.O.B. (Shortness of Breath) Controls and the Triage® Profiler S.O.B. Calibration Verification Controls

Device Description 4.

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integrity. The quality control materials are not calibrators and are not used to calibrate the Triage Test Devices.

5. Intended Use

The Triage Total Controls 5 are assayed materials to be used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test, and the Triage Meters to assist in monitoring test performance.

The Triage Total Calibration Verification 5 materials are to be used with the Triage Profiler S.O.B. Panel, Triage CardioProfilER Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to verify the calibration of the Test Devices throughout the measurable range.

6. Product Performance

The stability of the Triage Total Controls 5 and the Triage Total Calibration Verification 5 have been validated according to established procedures at the manufacturing site. The performance of the control materials are similar to other products in commercial distribution intended for similar use.

7. Comparison to Predicate Device

The Triage Total Controls 5 and Triage Total Calibration Verification 5 employ similar characteristics to the predicate device including multi-analytes assay control, 5 levels, liquid control, EDTA human plasma matrix and ≤ -20℃ storage condition.

8. Conclusion

The information presented in this Premarket Notification demonstrates the suitability of the device for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution. Further, the information presented herein indicate that the Triage Total Controls 5 and the Triage Total Calibration Verification 5 are substantially equivalent in intended use and performance to the Triage Profiler S.O.B. Controls and the Triage Profiler S.O.B. Calibration Verification Controls thereby, supporting 510(k) clearance

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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird with three faces in profile, facing to the right. The bird is encircled by text, which is arranged in a circular pattern around the bird. The text is difficult to read due to the image quality, but it appears to be the name of an organization or agency.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 0 7 2007

BioSite, Inc. c/o Mr. Fil V. Buenviaje Sr. Manager, Regulatory Compliance 9975 Summers Ridge Road San Diego, CA 92121

Re: K072892

Trade Name: Triage® Total Controls 5, Triage® Total Calibrator Verification 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: October 5, 2007 Received: October 16, 2007

Dear Mr. Buenviaje:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and 809); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.v.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K072892

Device Name:

Triage® Total Controls 5 Triage® Total Calibration Verification 5

Indications for Use:

Prescription Use (Per 21 CFR 801.109) x AND/OR

Over-The Counter Use (Per 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson

Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safetv Page 1 of

510(k) K072892

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.